Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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FDA Drug Recalls

6,161 recalls · Class II, newest first

Class II · Moderate risk

L-Arginine 100 mg/ml Injectable

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1441-2015
Class II · Moderate risk

Alprostadil 50 mcg/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1440-2015
Class II · Moderate risk

Alprostadil 40 mcg/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1439-2015
Class II · Moderate risk

Alprostadil 20 mcg/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1438-2015
Class II · Moderate risk

Alprostadil 10 mcg/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1436-2015
Class II · Moderate risk

Acetyl-L-Carnitine 500 mg/ml

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1434-2015
Class II · Moderate risk

5-Methyl Tetrahydrofolate

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1431-2015
Class II · Moderate risk

Cefepime HCl

Lack of Assurance of Sterility: Sterility of product is not assured.

Terminated Sterility / contamination Lincare, Inc. D-1199-2015

Recalls by year